FDA’s New “Pathway” to Improved Monitoring of Food and Drug Imports
Amid growing concerns over the safety of food and drug imports into the country, the U.S. Food and Drug Administration (FDA) recently released a plan to improve oversight and regulation of imported goods. The “Pathway to Global Product Safety and Quality” is part of the FDAs “new global strategy” under the Food Safety Modernization Act (FSMA) to monitor and inspect an increasing number of imports that cross into U.S. borders.
The FDA is responsible for overseeing the food, pharmaceutical and medical device products that enter into U.S. territory, as well as regulating the manufacturers and importers who produce these goods. The movement towards globalization and increased flow of capital, information, and goods across borders have put a strain on both the FDAs resources and ability to efficiently and effectively regulate the importation of goods. Over the next year alone, the FDA projects the number of shipments of FDA-regulated goods that will pass through the nations 300 ports of entry is expected to quadruple from 6 million to 24 million shipments.
This heavy influx of imported, globally-sourced goods has effectively created a regulatory nightmare for the FDA. In todays market, a product may move through different manufacturers or suppliers in multiple countries before reaching its final product stage or destination. Because goods are now entering the U.S. from new and different markets, the FDA is faced with the challenge to ensure that all entities in that multi-step chain comport with FDA regulations. The FDAs ability to sustain adequate regulatory functions has been impaired by these challenges.
In recent years, evidence of the FDAs struggle to keep up with the monitoring and regulation of imports has reached the publics eye. The New York Times published an article highlighting the FDAs failure to remove dangerous imported foods from the market. The article explained how the FDA failed to execute required audits or follow-up with companies about known contaminated food imports. Other events, such as heparin poisoning by a manufacturer, milk contamination, and counterfeit glucose monitoring strips, have put a spotlight on how the FDA has fallen short of its regulatory goals. As we blogged here earlier this year, the President even warned the FDA that it would likely be the target of a major overhaul due to its outdated processes and failure to keep up with advances in the rapidly changing market.
The new “Pathway to Global Product Safety and Quality” is the FDAs response to these mounting problems related to the importation of food and medical products. Under the FSMA, the FDA has a new mandate to require comprehensive, prevention-based controls. In addition, the FDA can now hold importers responsible for making sure that their foreign suppliers have adequate preventive controls to ensure the safety of foods shipped to the U.S. The FSMA also directs the FDA to inspect at least 600 foreign food facilities within the next year and to double the number of inspections every year for the next five years.
To help with the regulation of the medical device industry, the FDA has opened additional offices in key international locations and increased its number of foreign inspections. The FDA has also engaged in harmonization of drug regulation through the International Conference on Harmonization. In addition to working with Australia to create the Global Harmonization Task Force to expand the global regulation forum, the FDA also joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S), which is an informal organization of drug manufacturing inspectorates from 39 countries.
As part of its transformation “from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders,” the FDA is in the process of developing an international operating model as part of the new “Pathway to Global Product Safety and Quality” plan. The four tenets of this approach are:
- The FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.
- With these coalitions, the FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.
- The FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.
- The FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.
This operating model aims to provide the FDA with the information sharing and technological tools necessary to regulate a global market and to ensure the safety of Americans.
The FDAs new, extensive global plans raise serious questions about implementation. Even though these plans demonstrate that the FDA recognizes the deficiencies in its current scheme and understands what needs to be done to improve the regulation of imported goods into the U.S., these plans hardly seem feasible. For example, under the current model, the FDA has had difficulties inspecting a few hundred facilities annually, yet the Agency is expected to execute 19,200 food facility inspections in the plans sixth year. Without significant increases to agency personnel or third-party contractors and the threat of a smaller budget this fiscal year, the FDA seems to lack the manpower and resources to accomplish the goals set forth by the FSMA and in the new “Pathway to Global Product Safety and Quality” plan. The FDA does acknowledge in its new plan that it “does not”nor will it”have the resources to adequately keep pace with the pressures of globalization” and that constrained federal resources will prove challenging to the fulfillment of its goals. Even if the new global initiatives are successful in alleviating some of the FDAs current problems, it is still unclear as to whether the FDA will be able to implement any changes that produce discernible results or increased protection of the publics safety.
Fuerst Ittleman will continue to monitor the FDAs progress regulating the importation of foods and devices. For more information, please contact us at contact@fidjlaw.com.